使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Hello, and welcome to the Q3 2024 Teva Pharmaceuticals Industries Limited earnings conference call. My name is Alex, I'll be coordinating the call today. (Operator Instructions)
您好,歡迎參加梯瓦製藥工業有限公司 2024 年第三季財報電話會議。我叫亞歷克斯,今天我將協調通話。 (操作員說明)
I'll now hand over to your host, Ran Meir, Senior Vice President, Head of Investor Relations. Please go ahead.
現在我將請主持人、高級副總裁兼投資者關係主管 Ran Meir 發言。請繼續。
Ran Meir - Senior Vice President, Head of Investor Relations and Corporate Communications
Ran Meir - Senior Vice President, Head of Investor Relations and Corporate Communications
Thank you, Alex, and thank you, everyone, for joining us today. We hope you have had a chance to review our Q3 results press release, which was issued earlier this morning. A copy of the press release, along with the slides presented during this call are available on our website at ir.tevapharm.com. Please review our forward-looking statements on slide 2. Additional information regarding these statements and our non-GAAP financial measures is available on our earnings release and in our SEC Forms 10-K and 10-Q.
謝謝你,亞歷克斯,也謝謝大家今天加入我們。我們希望您有機會閱讀我們今天早上早些時候發布的第三季業績新聞稿。您可以在我們的網站 ir.tevapharm.com 上取得新聞稿的副本以及本次電話會議期間簡報的投影片。請查看幻燈片 2 上的前瞻性聲明。
To begin today's call, Richard Francis, Teva's CEO, will provide an overview of Teva's second quarter business performance, recent events and our focus and priorities going forward. Then Dr. Eric Hughes, our Head of R&D and Chief Medical Officer, will discuss progress on our innovative pipeline. Our CFO, Eli Kalif, will follow up by reviewing the third quarter financial results and our updated financial outlook in more detail. Please note that today's call will run approximately one hour.
在今天的電話會議中,Teva 執行長理查德·弗朗西斯 (Richard Francis) 將概述 Teva 第二季度的業務業績、最近發生的事件以及我們未來的重點和優先事項。然後我們的研發主管兼首席醫療官 Eric Hughes 博士將討論我們創新管道的進展。我們的財務長 Eli Kalif 隨後將更詳細地審查第三季的財務表現和我們更新的財務前景。請注意,今天的通話將持續約一小時。
And with that, I will now turn the call over to Richard. Richard, if you would, please?
現在,我將把電話轉給理查德。理查德,你願意嗎?
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thank you, Ran, and good morning, good afternoon, everybody. Thank you for joining Teva's third quarter 2024 results. So I'm going to walk you through a presentation today, which -- the backbone of it is in our Pivot to Growth strategy. And as you know, we launched this last year to get Teva back to growth, and it's focused on four pillars: deliver on our growth engines, step up innovation, create a sustainable generics powerhouse and focus the business.
謝謝你,蘭,大家早安,下午好。感謝您關注 Teva 2024 年第三季業績。因此,我今天將向您介紹一個演示,其核心是我們的「以成長為中心」策略。如您所知,我們去年推出了這項計劃,旨在讓 Teva 恢復成長,重點在於四大支柱:提供成長引擎、加強創新、創建可持續的仿製藥強國並專注於業務。
And through the presentation, myself, Eric and Eli will show the progress we're making across this strategy.
透過演示,我、艾瑞克和伊萊將展示我們在這項策略上的進展。
But just to give you some sort of areas to focus on, as you'll see and deliver on our growth engines, we are driving strong performance with our innovative portfolio of AUSTEDO, AJOVY and UZEDY. In step up innovation, Eric will show you the great work his team have done at building a deep pipeline that's coming to fruition, and we've got some exciting milestones and data points coming up in the near term.
但只是為了讓您專注於一些領域,正如您將看到並交付我們的成長引擎一樣,我們正在透過 AUSTEDO、AJOVY 和 UZEDY 的創新產品組合推動強勁的業績。在加強創新方面,埃里克將向您展示他的團隊在建立即將取得成果的深層管道方面所做的出色工作,並且我們在短期內將出現一些令人興奮的里程碑和數據點。
And then on our sustainable generics powerhouse, you'll see the performance we have across all of our regions, and I'll give you a bit of context as to what's driving that and what's behind that. And then finally, focus the business. We're very pleased to see that some of the credit ratings have looked at Teva and see the future is brighter.
然後,在我們的可持續仿製藥強國中,您將看到我們在所有地區的表現,我將為您提供一些背景信息,說明推動這一趨勢的因素及其背後的原因。最後,專注於業務。我們很高興看到一些信用評級機構開始關注梯瓦製藥,並看到其未來更加光明。
And also, we'll give you an update on TAPI and the divestment process there. But now moving on to the next slide. As you see, the consistency with which we are driving growth at Teva is impressive. From quarter one 2023 to now the 15% growth we see in quarter three 2024 shows the consistency, and this all comes from the execution of our strategy and the diligent focus we have on operations. Now let me go into a bit more detail as to what's behind this number, 15%.
此外,我們還將向您提供有關 TAPI 及其撤資流程的最新資訊。現在轉到下一張投影片。如您所見,我們推動 Teva 成長的一致性令人印象深刻。從 2023 年第一季到現在,我們在 2024 年第三季看到的 15% 的成長顯示了一致性,而這一切都來自於我們策略的執行和我們對營運的專注。現在讓我更詳細地解釋這個數字 15% 背後的含義。
Well, revenues of $4.3 billion, as I've said, up 15%. Adjusted EBITDA of $1.3 billion, up 17% and our EPS is up 16%. Also, we have strong free cash at $922 million and it's good to see that our net EBITDA is now touching three, shows our focus on our debt repayment. Now because of these strong financial results, we're going to be able to that give an increased outlook for the full year. And I'll leave that pleasure to Eli Kalif, my CFO, to talk about a bit later in the presentation.
正如我所說,收入為 43 億美元,成長了 15%。調整後 EBITDA 為 13 億美元,成長 17%,每股盈餘成長 16%。此外,我們擁有 9.22 億美元的強勁自由現金,很高興看到我們的 EBITDA 淨值現已達到 3,這表明我們對債務償還的關注。現在,由於這些強勁的財務業績,我們將能夠提高全年的前景。我將把這種榮幸留給我的財務長 Eli Kalif,他將在稍後的演示中談論這一點。
But now to go into a bit more detail as what's behind this 15% growth. As you can see from this slide, what I'm pleased about in this slide is the fact that our innovative business, our generics business and our TAPI business are all driving growth. As you see, AUSTEDO continues to perform impressively with 28% growth. AJOVY at 21% is our global driver. And then UZEDY, a strong launch and momentum there, and I'll go into a bit more detail later about what's behind that.
但現在更詳細地了解 15% 成長背後的原因。正如您從這張投影片中看到的,我在這張投影片中感到高興的是我們的創新業務、我們的仿製藥業務和我們的 TAPI 業務都在推動成長。如您所見,AUSTEDO 繼續以 28% 的成長率表現出色。 21% 的 AJOVY 是我們的全球驅動力。然後是 UZEDY,那裡有強勁的啟動和勢頭,稍後我將更詳細地介紹其背後的內容。
Then we have a 17% growth in our global generics business, and you'll see that, that comes from all of the regions. And in TAPI, its third quarter of return to growth. We returned to growth in Q1. We cemented that in Q2, and now we're solidifying that in Q3. But let me double click on each one of these to give you a bit more detail.
然後,我們的全球仿製藥業務成長了 17%,您會看到,這一成長來自所有地區。而在 TAPI 方面,其第三季恢復了成長。我們在第一季恢復了成長。我們在第二季鞏固了這一點,現在我們在第三季鞏固了這一點。但讓我雙擊其中的每一個,為您提供更多詳細資訊。
So starting with AUSTEDO, $435 million for Q3, impressive growth of 28% and strong TRx growth of 36%. So the team are doing an exceptional job here and I'd like to reaffirm the guidance of $1.6 billion for AUSTEDO for the full year. Now moving on to AJOVY, the oldest member of our innovative family, but it still continues to impress, a 21% growth versus the quarter three 2023. What I like about this, this is a highly competitive market, but it shows what Teva can do across all of its regions, all of its geographies and with this level of competition. And as you can see, regardless of which area you look at market share is impressive, whether it's in Europe, whether it's in international markets or whether it's in the US, showing the full muscle that we have in our commercial teams.
因此,從 AUSTEDO 開始,第三季的營收為 4.35 億美元,成長了 28%,TRx 成長了 36%。因此,團隊在這裡做得非常出色,我想重申 AUSTEDO 全年 16 億美元的指引。現在轉向AJOVY,我們創新家族中最古老的成員,但它仍然給人留下了深刻的印象,與2023 年第三季度相比增長了21%。市場,但它展示了Teva 的能力在其所有地區、所有地區以及這種水平的競爭中開展業務。正如你所看到的,無論你看哪個地區的市場份額都是令人印象深刻的,無論是在歐洲,無論是在國際市場還是在美國,這都顯示了我們商業團隊的全部實力。
Now moving on to UZEDY, which is the newest member of our family, our innovative family. Good momentum with our launch. US revenues of $35 million in Q3 24, and that gives us a year-to-date number of $75 million. Because of this strong performance, we're increasing guidance for the full year, up from $80 million to $100 million.
現在轉向 UZEDY,它是我們創新家族的最新成員。我們的推出勢頭良好。 24 年第三季美國的營收為 3,500 萬美元,而今年迄今的營收為 7,500 萬美元。由於業績強勁,我們將全年指導金額從 8,000 萬美元提高到 1 億美元。
And what's behind this really is above from excellent execution by the team here in the US, it's also driven by a great product profile that meets both physicians and patients' needs. And Eric has talked about that on many occasions. But just to reiterate, this is a product which is subject to (inaudible) that doesn't have to be refrigerated. And very importantly, for a physician, it allows the patient to get to therapeutic dose within 8 to 24 hours, which is a very important criteria when treating these patients. So great work with UZEDY, and I look forward to seeing continued momentum there.
這背後的真正原因在於美國團隊的出色執行力,同時也受到滿足醫生和患者需求的出色產品檔案的推動。埃里克在很多場合都談到這一點。但重申一下,這是一種無需冷藏(聽不清楚)的產品。非常重要的是,對於醫生來說,它可以讓患者在 8 至 24 小時內達到治療劑量,這是治療這些患者時非常重要的標準。與 UZEDY 的合作非常出色,我期待看到那裡的持續發展勢頭。
Now staying with innovation, I'd like to move on to our pipeline but only briefly because I want to leave that to Eric to go in a bit more detail. But I think what I'd like to show is just the progress we're making and the depth we're creating in our innovative pipeline. But obviously, there are some exciting catalysts coming up. I'd like to highlight the fact that we have achieved the Phase III target injections without any PDSS in our olanzapine study, so very excited about that. And obviously, when it comes to our TL1A there is a news to be announced towards the end of this year, but Eric will give you more detail on that.
現在繼續創新,我想繼續討論我們的管道,但只是簡單地討論一下,因為我想把它留給埃里克來更詳細地討論。但我認為我想展示的只是我們正在取得的進展以及我們在創新管道中創造的深度。但顯然,一些令人興奮的催化劑即將出現。我想強調的是,我們在奧氮平研究中已經實現了沒有任何 PDSS 的 III 期目標注射,對此感到非常興奮。顯然,當談到我們的 TL1A 時,有一個消息將在今年年底宣布,但 Eric 將為您提供更多詳細資訊。
Now moving on to biosimilars. Another area we're excited about to drive our pivot to growth in the short, medium and long term. We're pleased with the fact that our Prolia biosimilar has been accepted for review by the US FDA and the EU EMEA. And because of this, we anticipate a decision by both agencies in the second half of next year.
現在轉向生物相似藥。我們很高興推動我們的短期、中期和長期成長的另一個領域。我們很高興我們的 Prolia 生物相似藥已被美國 FDA 和歐盟 EMEA 接受審查。因此,我們預計兩家機構將在明年下半年做出決定。
Just to remind you, this product is a $3 billion brand. And so once again, we see good opportunity to drive growth for Teva in the short, medium and long term. Now moving on to the biosimilar portfolio as a whole. As you can see, we are building a big portfolio. It's up to 17 biosimilars now.
只是提醒您一下,該產品是一個價值 30 億美元的品牌。因此,我們再次看到了推動 Teva 在短期、中期和長期成長的良好機會。現在轉向整個生物相似藥產品組合。正如您所看到的,我們正在建立一個龐大的產品組合。目前已有多達 17 種生物相似藥。
And as you see, this target is nearly $60 billion of brand value. What I'm pleased about here is we have a number of launches coming up in short term, but we are building a long-term portfolio to drive our growth, both medium and long term. And as you can see on this slide and an announcement we made in Q3. We do have -- we have started a collaboration with (inaudible) Science, where we bought two -- we partnered on two oncology biosimilar assets. So once again, building out the depth of our stable of biosimilars here.
正如您所看到的,這個目標是近 600 億美元的品牌價值。我很高興的是,我們在短期內推出了許多產品,但我們正在建立一個長期的投資組合,以推動我們的中長期成長。正如您在這張投影片和我們在第三季發布的公告中看到的。我們確實——我們已經開始與(聽不清楚)Science 合作,我們在那裡購買了兩個——我們合作開發了兩個腫瘤生物仿製藥資產。因此,再次擴大我們生物相似藥穩定的深度。
Now moving from biosimilars to generics. Impressive growth of generics, 17% globally, and really pleased to see this growth continue across all regions. As you can see here, the US is up 30%, EU is up 8%, and our international market is up 13%, all in local currency. And what's behind this is the work we've been doing for the last 20 months, focusing on product launches, focusing on supply chain and commercial execution.
現在從生物相似藥轉向仿製藥。仿製藥的成長令人印象深刻,全球成長了 17%,我們很高興看到這種成長在所有地區持續下去。正如您在這裡看到的,美國上漲了 30%,歐盟上漲了 8%,我們的國際市場上漲了 13%,全部以當地貨幣計算。這背後是我們過去20個月一直在做的工作,專注於產品發布、專注於供應鏈和商業執行。
And I think it shows we're getting traction across all regions of Teva with driving our generics business forward. Now the final part of that growth that I talked about in the earlier slide was TAPI, and this is the third quarter of growth for TAPI, 4%. So congratulations to the team and this shows that their strategy is working. The continued focus on our CDMO expansion is gaining traction and the 4% growth is a result of that. I would like to highlight that we are on track for our divestment in H1 of 2025.
我認為這表明我們在梯瓦所有地區都受到了關注,推動了我們的仿製藥業務向前發展。現在,我在前面的幻燈片中談到的成長的最後一部分是 TAPI,這是 TAPI 第三季的成長,4%。祝賀我們的團隊,這表明他們的策略正在發揮作用。對 CDMO 擴張的持續關注正在獲得關注,4% 的成長就是由此產生的。我想強調的是,我們預計在 2025 年上半年進行撤資。
Now with that, I would like to hand over to Eric Hughes, who will walk you through some of that exciting pipeline I was talking about. Over to you, Eric.
現在,我想把時間交給 Eric Hughes,他將引導您完成我正在談論的一些令人興奮的流程。交給你了,艾瑞克。
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Thank you, Richard. Let me start off with our anti-TL1A program. I'm very proud of our Duvakitug team for accelerating this program, and we're really excited to the top line results that's on track for the fourth quarter of this year. Just as a reminder, it's a study that includes both ulcerative colitis & Crohnâs disease. It has 240 patients, 120 for each indication, and we have two doses against placebo.
謝謝你,理查。讓我從我們的抗 TL1A 程式開始。我為我們的 Duvakitug 團隊加速該計劃感到非常自豪,我們對今年第四季有望實現的頂線結果感到非常興奮。提醒一下,這項研究包括潰瘍性結腸炎和克隆氏症。它有 240 名患者,每種適應症 120 名患者,我們有兩種劑量的安慰劑。
This is the induction phase of the study, and the primary endpoint is at week 14. And just to remind everyone, the primary endpoint for ulcerative colitis will be clinical remission using the Modified Mayo Score. And for Crohn's disease, it will be the endoscopic readout. So we're very excited about that. The team has done a great job.
這是研究的誘導階段,主要終點是在第 14 週。對於克羅恩病,它將是內視鏡讀數。所以我們對此感到非常興奮。該團隊做得很好。
Moving on to the olanzapine LAI program, which is right on track. We've now presented our period one of the study. That's the 8-week endpoint. And you can see here that our PAM score was right on target with all three doses that was presented last month externally. And we're very excited about this program because this is a program with a formulation that's specifically designed to prevent PDFF.
接下來是奧氮平 LAI 項目,該項目正步入正軌。我們現在已經介紹了第一階段的研究。這是 8 週的終點。您可以在這裡看到,我們的 PAM 分數完全符合上個月外部提供的所有三劑劑量的目標。我們對這個計劃感到非常興奮,因為這個計劃的配方是專門為預防 PDFF 而設計的。
We have not seen that to date.
到目前為止我們還沒有看到這一點。
And as Richard mentioned, we've exceeded the target that we have designed into the program as expected. We'll be bringing our last patient in at the end of this year. and we will be presenting that data in the first half of 2025. So very excited to get the full data set presented externally.
正如理查德所提到的,我們已經超越了我們為該計劃設計的預期目標。我們將在今年底引進最後一位患者。我們將在 2025 年上半年提供這些數據。
Moving on to anti-IL-15 program. We have now presented our Phase I data last month. We already enrolled our POC study in Celiac disease. This is a high affinity anti-IL-15 antibody that really actually has great, robust, rapid and prolonged effects on free IL-15. You can see in this graph that in fact, we have suppression at the higher dose here almost out to 80 days.
繼續進行抗 IL-15 計劃。我們現在已經公佈了上個月的第一階段數據。我們已經登記了乳糜瀉的 POC 研究。這是一種高親和力抗 IL-15 抗體,實際上對遊離 IL-15 具有巨大、穩健、快速且持久的作用。您可以在此圖中看到,事實上,我們在較高劑量下的抑制時間幾乎長達 80 天。
So we're very happy to see these initial Phase I results. We're glad to be in Celiac disease already. But I'd also like to announce today that we've now initiated our second indication for our anti-IL-15 program, expanding the potential of this multi-indication product.
因此,我們很高興看到這些第一階段的初步結果。我們很高興已經患有乳糜瀉。但我今天還想宣布,我們現在已經啟動了抗 IL-15 計畫的第二個適應症,擴大了這種多適應症產品的潛力。
Vitiligo, if you don't know, is an autoimmune disease that impacts patients' quality of life by really depleting the melanocytes in the skin, causing a discoloration. And this can be highly impactful on us and it has a psychological burden on patients with impressing -- a lot of depression and anxiety in their daily life. For many of the patients, over 1/3 of these patients had more than 10% of their body affected. And we believe that IL-15 is a key cytokine in blocking these cytotoxic T cells from depleting monocytes in the skin. And why is this important?
如果你不知道的話,白斑症是一種自體免疫疾病,它會消耗皮膚中的黑色素細胞,導致變色,從而影響患者的生活品質。這對我們影響很大,給患者帶來了令人印象深刻的心理負擔——日常生活中有很多憂鬱和焦慮。對於許多患者來說,超過 1/3 的患者身體的 10% 以上受到影響。我們相信 IL-15 是阻止這些細胞毒性 T 細胞消耗皮膚中單核細胞的關鍵細胞激素。為什麼這很重要?
Well, there are treatments with topical treatments, but since this is such an extensive disease for some patients, having a safe and effective and easily given systemic treatment is really needed. So we're very excited about starting that study and enrolling our first patient. And finally, moving on to emrusolmin. We're very pleased to announce that we've enrolled our first subject here, where we're running a robust Phase II study with 200 participants against placebo for full 48 weeks. And just to remind you, emrusolmin is a small molecule that penetrates the brain and reaches the site of where the alpha-synuclein is being produced in the brain cells.
嗯,有局部治療的方法,但由於這對某些患者來說是一種廣泛的疾病,因此確實需要安全有效且易於進行的全身性治療。因此,我們對開始這項研究並招募我們的第一位患者感到非常興奮。最後,繼續使用 emrusolmin。我們非常高興地宣布,我們已經在這裡招募了第一個受試者,我們正在進行一項為期 48 週、有 200 名參與者對照安慰劑的強大 II 期研究。提醒您一下,emrusolmin 是一種小分子,可以穿透大腦並到達腦細胞中產生 α-突觸核蛋白的部位。
And these alpha-synuclein aggregates are the genesis of the problem that's terribly degenerative and relentless disease that most people are on a wheelchair by five years after diagnosis. And frequently, many don't survive past 10 to 12 years. So a high unmet medical need. We're making sure this is a very robust study, and we've enrolled our patient just last month. And finally, I just want to go over the slide that Richard had briefly mentioned.
這些α-突觸核蛋白聚集體是這種嚴重退化性和無情疾病問題的根源,大多數人在診斷後五年就必須坐在輪椅上。通常,許多人活不過 10 到 12 年。因此,未滿足的醫療需求很高。我們確保這是一項非常穩健的研究,並且我們上個月剛招募了我們的患者。最後,我只想回顧理查簡短提到的幻燈片。
I hope you can see from this slide that we have a robust innovative pipeline in multiple indications with multiple novel molecules. Our olanzapine LAI is on track. We'll have our full study safety readout in the first half of 2025. Our Duvakitug program is right on track with our top line results coming out in the Q4 of this year and also requires and Crohn's disease. We've expanded anti-IL-15 from Celiac disease and into vitiligo, we working on initiating that study, which I mentioned, we have already started.
我希望您可以從這張投影片中看到,我們在多種適應症和多種新型分子方面擁有強大的創新管道。我們的奧氮平 LAI 已步入正軌。我們將在 2025 年上半年公佈完整的研究安全性。我們已經將抗 IL-15 從乳糜瀉擴展到白斑,我們正在努力啟動這項研究,我提到過,我們已經開始了。
Our anti-PD-1 IL-2 has enrolled its first -- or (inaudible) its first patient, and we're looking to fully enroll that study in the second half of 2026.
我們的抗 PD-1 IL-2 已招募了第一位——或者說(聽不清楚)第一位患者,我們希望在 2026 年下半年全面招募研究。
Our ICS SABA, our dual action rescue inhaler for asthma is rapidly enrolling in Phase III, and we're working to accelerate that as fast as possible. And finally, as I mentioned, emrusolmin has enrolled its first patient and multiple system atrophy, a great unmet medical need that we're proud to be in. And with that, I'll pass it off to Eli Kalif.
我們的 ICS SABA(氣喘雙效救援吸入器)正在迅速進入 III 期臨床,我們正在努力盡快加快這一進程。最後,正如我所提到的,emrusolmin 已經招募了第一位患者和多系統萎縮症患者,這是一個巨大的未滿足的醫療需求,我們對此感到自豪。 。
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Thank you, Eric, and good morning and good afternoon to everyone. I'll begin a review of our Q3 2024 financial results with slide 24, starting with our GAAP performance. Revenues in the third quarter of 2024 were $4.3 billion, an increase of 13% in US dollars or 15% in local currency terms compared to the third quarter of 2023.
謝謝你,艾瑞克,祝大家早安,下午好。我將從幻燈片 24 開始回顧我們 2024 年第三季的財務業績,首先是我們的 GAAP 表現。 2024年第三季營收為43億美元,與2023年第三季相比,以美元計算成長13%,以當地貨幣計算成長15%。
The increase in revenue was mainly driven by growth from generics products across all our segments globally, including continued strong contribution from generics Revlimid and from the recent launch of generic Victoza in the US and a strong growth from our key innovative products, including AUSTEDO, AJOVY and UZEDY as well as from the sale of certain product rights in our Europe and international market segments.
營收的成長主要得益於我們全球所有細分市場的仿製藥產品的成長,包括仿製藥Revlimid 和最近在美國推出的仿製藥Victoza 的持續強勁貢獻,以及我們的關鍵創新產品(包括AUSTEDO、AJOVY)的強勁成長和 UZEDY 以及我們在歐洲和國際市場部分銷售某些產品權利。
Foreign exchange rate movements during the third quarter of 2024 and the year to date, including hedging effect, have negatively impacted our revenues and profitability compared to the same period last year. with a negative year-to-date impact of approximately $250 million on our revenue and $190 million on our gross profit mainly as a result of a stronger US dollar against the currencies of certain international markets in which we operate.
與去年同期相比,2024 年第三季和今年迄今的匯率變動(包括對沖效應)對我們的營收和獲利能力產生了負面影響。年初至今,我們的營收受到約 2.5 億美元的負面影響,毛利受到約 1.9 億美元的負面影響,主要是由於美元兌我們經營所在的某些國際市場的貨幣走強。
In Q3 2024, we recorded a GAAP operating loss of $51 million compared to a GAAP operating income of $344 million in the same quarter last year.
2024 年第三季度,我們的 GAAP 營運虧損為 5,100 萬美元,而去年同期的 GAAP 營運收入為 3.44 億美元。
This reduction was mainly due to a goodwill impairment charges related to our API reporting unit and a higher legal settlement and loss contingencies recorded in the third quarter of 2024, partially offset by higher gross profit. GAAP net loss in Q3 2024 was $437 million and a GAAP loss per share was $0.39, compared to a net income of $69 million and an earnings per share of $0.06 in Q3 of last year. The higher GAAP net loss in the third quarter of 2024 was mainly due to the operating loss that I just discussed.
這一減少主要是由於與我們的 API 報告部門相關的商譽減損費用以及 2024 年第三季記錄的更高的法律和解和損失意外費用,部分被更高的毛利所抵消。 2024 年第三季的 GAAP 淨虧損為 4.37 億美元,每股 GAAP 虧損為 0.39 美元,而去年第三季的淨利潤為 6,900 萬美元,每股收益為 0.06 美元。 2024 年第三季 GAAP 淨虧損較高,主要是因為我剛才討論的營運虧損。
Turning to slide 25. You can see that the total non-GAAP adjustment in the third quarter of 2024 were $1.2 billion, this include a $600 million goodwill impairment charge related to our API reporting unit, in line with our intention to divest this business.
轉向投影片25。意圖。
In addition, we recorded a legal settlement and loss contingencies of $450 million including a provision of $350 million in connection with the decision by the European Commission and its antitrust investigation into COPAXONE, which we intend to appeal.
此外,我們還記錄了 4.5 億美元的法律和解和意外損失,其中包括與歐盟委員會的決定及其對 COPAXONE 的反壟斷調查相關的 3.5 億美元準備金,我們打算對此提出上訴。
Now moving to slide 26 for a review of our non-GAAP performance. As I mentioned earlier, our third quarter revenues were $4.3 billion, an increase of 13% in US dollars or 15% in local currency terms compared to Q3 of last year. Our non-GAAP gross profit margin was 53.7% and compared to 53.5% in Q3 of last year and 52.9% in the second quarter of 2024.
現在轉到幻燈片 26,回顧我們的非 GAAP 業績。正如我之前提到的,我們第三季的營收為 43 億美元,與去年第三季相比,以美元計算成長了 13%,以當地貨幣計算成長了 15%。我們的非 GAAP 毛利率為 53.7%,去年第三季為 53.5%,2024 年第二季為 52.9%。
This improvement in our non-GAAP gross profit margin was mainly driven by expected improvement in our portfolio mix, primarily AUSTEDO, partially offset by an adverse impact from foreign exchange movements, including hedging effects that I just mentioned. We expect our gross margin to further improve in the fourth quarter with a further ramp in Q4 revenue and continuation of our cost optimization efforts. Non-GAAP operating margin was 28% in Q3 2024 compared to 26.5% in Q3 2023.
我們的非公認會計準則毛利率的改善主要是由於我們的投資組合組合(主要是 AUSTEDO)的預期改善所推動的,部分被外匯波動的不利影響所抵消,包括我剛才提到的對沖效應。我們預計,隨著第四季度收入的進一步增長和成本優化工作的繼續,我們的毛利率將在第四季度進一步提高。 2024 年第三季的非 GAAP 營業利潤率為 28%,而 2023 年第三季為 26.5%。
The increase in the non-GAAP operating margin in the third quarter of 2024 was mainly due to lower operating expenses as a percentage of revenue, consistent with our expectation of the second half of the year and reflecting a higher revenue. The lower spend on R&D in the third quarter was largely due to a benefit of reimbursement from our strategic partnership to support our key late-stage innovative programs.
2024 年第三季非 GAAP 營運利潤率的成長主要是由於營運費用佔收入的百分比降低,這與我們對下半年的預期一致,並反映出收入的增加。第三季研發支出較低,主要是由於我們的策略合作夥伴關係為支持我們關鍵的後期創新項目提供了報銷。
We continue to invest both in our existing innovative portfolio as well in our pipeline. As Eric highlighted earlier, we are looking forward to sharing Phase II top line results this quarter for our anti-TL1A program in partnership with Sanofi as well as olanzapine LAI full Phase III external readout in the first half of 2025. Turning to EPS.
我們持續投資於現有的創新產品組合以及管道。正如Eric 之前所強調的那樣,我們期待在本季度分享我們與賽諾菲合作的抗TL1A 項目的II 期頂線結果,以及奧氮平LAI 的完整III 期外部讀數在2025 年上半年。收益。
We ended the quarter with a non-GAAP earnings per share of $0.69 compared to $0.60 in Q3 2023, mainly driven by higher non-GAAP operating income I just discussed. Now moving to slide 27, which will highlight steady improvements in our margins and cash flow as we continue to invest in our business to drive short- and long-term growth.
本季末,我們的非 GAAP 每股盈餘為 0.69 美元,而 2023 年第三季為 0.60 美元,這主要是由於我剛才討論的非 GAAP 營業收入的增加。現在轉到幻燈片 27,它將突出顯示我們的利潤和現金流的穩定改善,因為我們繼續投資於我們的業務以推動短期和長期成長。
As you can see, our gross margin and gross profit has gradually improved throughout this year, driven by our portfolio mix and disciplined cost management. As part of our pivotal growth strategy, we are also constantly reviewing our generic product portfolio to rationalize where it makes sense, with a focus of the long-term profitability and sustainability.
正如您所看到的,在我們的投資組合組合和嚴格的成本管理的推動下,我們的毛利率和毛利在今年逐漸改善。作為我們關鍵成長策略的一部分,我們也不斷審查我們的通用產品組合,以在有意義的地方進行合理化,重點關注長期獲利能力和永續性。
And at the same time, we continue to make focus on investment to support our growing innovative portfolio through our marketing and other initiatives as well as the progress on our key pipeline assets, leading to higher operating expenses. We expect these dynamics to continue in the fourth quarter with a further improvement in our margins, consistent with our full year guidance. We also remain focused on optimizing our working capital management.
同時,我們繼續注重投資,透過行銷和其他舉措以及關鍵管道資產的進展來支持我們不斷增長的創新產品組合,從而導致營運費用增加。我們預計這些動態將在第四季度持續,我們的利潤率將進一步提高,這與我們的全年指導一致。我們也持續致力於優化營運資金管理。
Over the past few years, we have strategically put the programs in place to ensure that our operational processes, commercial terms and financial solutions supporting (inaudible) sales with a reduced net working capital investment. As a result, we have achieved significant improvement in our net working capital as a percentage of revenue.
在過去的幾年裡,我們策略性地實施了這些計劃,以確保我們的營運流程、商業條款和財務解決方案支援(聽不清楚)銷售,同時減少淨營運資本投資。因此,我們的淨營運資本佔收入的百分比得到了顯著改善。
Our free cash flow in the third quarter of 2024, and year to date reflects this progress we have made throughout this year. The year-to-date increase of 42% in our free cash flow compared to last year is driven by higher net profit, driven by revenue mix as well as our ongoing efforts to improve our working capital management, partially offset by higher legal payments.
我們 2024 年第三季和年初至今的自由現金流反映了我們今年的進展。與去年相比,今年迄今為止我們的自由現金流增長了 42%,這是由於淨利潤增加、收入組合以及我們持續努力改善營運資本管理所推動的,但部分被較高的法律費用所抵消。
As a reminder, during the third quarter of 2024, we made the second payment of the nationwide settlement in connection with the opioid litigation.
謹此提醒,我們在 2024 年第三季支付了與鴉片類藥物訴訟相關的全國和解金的第二筆款項。
Our free cash flow year to date includes $390 million of opioid legal settlement payment, which was an increase of $210 million compared to the first nine months of 2023. Excluding these payments, our cash conversion year to date was 82%. Reflecting on these results, we are reaffirming our 2024 full year free cash flow guidance range of $1.7 billion to $2 billion, which we initially provided in January.
我們年初至今的自由現金流包括 3.9 億美元的阿片類藥物法律和解付款,與 2023 年前 9 個月相比增加了 2.1 億美元。考慮到這些結果,我們重申我們最初於 1 月份提供的 2024 年全年自由現金流指引範圍為 17 億美元至 20 億美元。
Turning to slide 28. As you can see, we continue to reduce our net debt, which was $15.7 billion at the end of Q3 2024.
轉向投影片 28。
Our gross debt was $19 billion compared to $19.8 billion at the end of 2023. This decrease in our gross debt was mainly due to a repayment of $956 million of 6% senior notes at maturity in April 2024, partially offset by $88 million from exchange rate fluctuations. Our net debt to EBITDA further improved during the third quarter coming at 3x, reflecting the ongoing progress with our free cash flow generation as well as higher EBITDA.
我們的總債務為190 億美元,而2023 年底為198 億美元。抵消波動。我們的 EBITDA 淨負債在第三季進一步改善,達到了 3 倍,反映出我們在自由現金流產生方面不斷取得的進展以及更高的 EBITDA。
After the quarter closed on September 30 in mid of October, we also repaid the maturity of another $685 million of our senior notes. Currently, there are no additional maturities outstanding for 2024.
9 月 30 日季度結束後,我們也於 10 月中旬償還了另外 6.85 億美元到期的優先票據。目前,2024 年沒有其他到期的債券。
As of September 30, and as of today, there is no amount outstanding under our $1.8 billion revolving credit facility. Moving to the next slide. I want to share how the execution of our Pivot to Growth strategy, along with our disciplined capital allocation policy over the last several quarters has started to be recognized by the leading credit rating agencies.
截至 9 月 30 日以及今天,我們的 18 億美元循環信貸安排中沒有任何未償還金額。轉到下一張投影片。我想分享我們的「以成長為中心」策略的執行以及過去幾季嚴格的資本配置政策如何開始得到領先信用評級機構的認可。
In June, S&P upgraded outlook to Teva credit from stable to positive, reflecting improved growth prospects and continued deleveraging of our balance sheet while maintaining our BB minus rating. In the last two months, both Fitch and Moody's have also agreed to Teva credit outlook, with Fitch upgrading our rating to BB.
6 月份,標準普爾將 Teva 信用評等展望從穩定上調至正面,反映出成長前景改善以及資產負債表持續去槓桿化,同時維持 BB 負評等。過去兩個月,惠譽和穆迪也同意 Teva 的信用前景,惠譽將我們的評等上調至 BB。
The upgrade by Fitch marked the first time in over a decade that Teva's credit ratings has been upgraded. This upgrade reflects our focused and consistent execution of the strategy on multiple fronts, including return to and delivering sustainable growth, significant ongoing progress in reduction in our debt, improving operational efficiency and putting uncertainties related to legacy litigation behind us.
惠譽的此次升級標誌著梯瓦公司信用評級十多年來首次升級。此次升級反映了我們在多個方面集中一致地執行該策略,包括回歸併實現可持續增長、在減少債務方面持續取得重大進展、提高營運效率以及消除與遺留訴訟相關的不確定性。
We are pleased with these upgrades and remain committed to achieving an investment-grade rating. Now let's turn our attention to our 2024 non-GAAP outlook on slide 30. As Richard highlighted earlier, our year-to-date results reflect solid progress across our business.
我們對這些升級感到滿意,並將繼續致力於實現投資級評級。現在讓我們將注意力轉向幻燈片 30 上的 2024 年非 GAAP 展望。
Our key innovative products continued to see strong growth driven by significant unmet needs in the markets we serve and supported by our focused investment to drive awareness and improve patient experience. With the year-to-date revenue progress with UZEDY, we are now expecting UZEDY revenue for the full year to be at $100 million compared to our prior expectation of $80 million, reflecting solid demand and growing adoption.
我們的主要創新產品持續強勁成長,這得益於我們所服務的市場中未滿足的巨大需求,以及我們為提高意識和改善患者體驗而進行的重點投資的支持。隨著 UZEDY 年初至今的營收進展,我們目前預計 UZEDY 全年營收將達到 1 億美元,而我們先前預期的為 8,000 萬美元,這反映出強勁的需求和日益增長的採用。
We also expect COPAXONE revenue to be higher than our previous guidance, reflecting lower-than-expected erosion from competing therapies. In addition to the strong momentum in our innovative portfolio, our core generics business continued to perform well across all our key markets. Therefore, to reflect our results in the first 9 months and expected performance in the fourth quarter, we are raising our 2024 full year revenue guidance to $16.1 billion to $16.5 billion.
我們也預期 COPAXONE 的收入將高於我們先前的指導,反映出競爭療法的侵蝕低於預期。除了我們創新產品組合的強勁勢頭之外,我們的核心仿製藥業務在所有主要市場上繼續表現良好。因此,為了反映我們前 9 個月的業績和第四季度的預期業績,我們將 2024 年全年營收指引上調至 161 億美元至 165 億美元。
This reflects an increase of $100 million from the previous guidance range we provided last quarter. We are also raising the lower end of 2024 non-GAAP outlook for operating income and EBITDA by $100 million and our earnings per share guidance range by $0.10 to be between $2.40 and $2.50.
這比我們上季度提供的指導範圍增加了 1 億美元。我們也將 2024 年非 GAAP 營業收入和 EBITDA 展望下限調高 1 億美元,每股收益指引範圍上調 0.10 美元,至 2.40 美元至 2.50 美元之間。
We continue to expect our non-GAAP gross margin to be between 53% to 54% for the full year with a further improvement in our fourth quarter and operating expenses to be in the 27% to 27.5% range for the full year as provided at the beginning of the year. And as I mentioned earlier, free cash flow are expected to be between $1.7 billion to $2 billion for the full year. With this, I conclude my review of Teva's results for the third quarter of 2024.
我們繼續預計全年非 GAAP 毛利率將在 53% 至 54% 之間,第四季將進一步改善,全年營運費用將在 27% 至 27.5% 之間。正如我之前提到的,全年自由現金流預計在 17 億至 20 億美元之間。至此,我結束了對 Teva 2024 年第三季業績的回顧。
And now I will hand it back to Richard for a summary.
現在我將把它交還給理查德進行總結。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thank you, Eli, and thank you, Eric. So moving on to our financial targets for 2027. We're on track to meet these. And I think you can see from the robustness of our business across all segments. You can see the confidence we have in meeting these targets, mid-single-digit growth operating income margin of 30%, net debt adjusted EBITDA of 2x and cash to earnings of 80%.
謝謝你,伊萊,謝謝你,艾瑞克。接下來我們將討論 2027 年的財務目標。我認為您可以從我們所有細分市場的業務穩健性中看到這一點。您可以看到我們對實現這些目標的信心:營運利潤率實現 30% 的中位數個位數成長,淨債務調整後 EBITDA 為 2 倍,現金收益比為 80%。
Now moving on to my final slide. is to reiterate that we are executing with precision, our pivot to growth strategy. This is a strategy, I think we've shown really good traction over the last 20 months, but also I'd like to highlight that we see the potential going forward. Some of the things we've highlighted in our pipeline around olanzapine, ICS SABA, the biosimilar portfolio. The generics business has now moved from stabilization to growth.
現在轉到我的最後一張投影片。是重申我們正在精確執行我們的成長策略。這是一項策略,我認為我們在過去 20 個月中表現出了非常好的吸引力,但我想強調的是,我們看到了未來的潛力。我們在圍繞奧氮平、ICS SABA 和生物仿製藥產品組合的管道中強調了一些事情。仿製藥業務現已從穩定轉向成長。
We have many opportunities in this Pivot to Growth strategy to keep growing the company over the short, medium and long term. So with that, I'd like to conclude the presentation and open up the floor to questions.
在這個以成長為中心的策略中,我們有很多機會來維持公司在短期、中期和長期的發展。因此,我想結束演講並開始提問。
Operator
Operator
(Operator Instructions) Our first question for today comes from Umer Raffat of Evercore ISI.
(操作員說明)我們今天的第一個問題來自 Evercore ISI 的 Umer Raffat。
Umer Raffat - Analyst
Umer Raffat - Analyst
Congrats on all the execution. I have three, if I may. First, I'm curious what your expectation is on placebo response in the TL1A Phase II trial coming up? Second, on UZEDY, the launch performance is clearly now tracking ahead. And I wonder, what does that mean for you in terms of how you're thinking about the peak sales for long-acting olanzapine?
祝賀所有執行。如果可以的話,我有三個。首先,我很好奇您對即將到來的 TL1A II 期試驗中安慰劑反應的期望是什麼?其次,在 UZEDY 上,發射性能現在顯然正在領先。我想知道,這對您如何看待長效奧氮平的高峰銷售意味著什麼?
And then finally, on long-acting olanzapine, I noticed you have a new trial of three extended-release formulations with different release rates. Why do that at this point?
最後,關於長效奧氮平,我注意到你們對三種具有不同釋放速率的緩釋製劑進行了一項新試驗。為什麼要在這個時候這麼做呢?
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Umer, thanks for the questions. I will hand over the first one TL1A to the Q2 to Eric, and then I'll take the UZEDY one and then hand you back to olanzapine one.
烏默,謝謝你的提問。我會把第一個TL1A交給Eric,然後把Q2交給Eric,然後我拿走UZEDY,然後把你還給奧氮平。
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Thanks, Richard, and thanks Umer for the question. So placebo responses in Ulcerative Colitis & Crohnâs Disease are variable. You can see in the study that have been recently completed, there are differences. Sometimes those differention are related to how they calculate certain aspects of the modified Mayo score. But it's hard to predict, and I'll just leave it at that with regard to the study.
謝謝理查德,也謝謝烏默提出的問題。因此,潰瘍性結腸炎和克隆氏症的安慰劑反應是可變的。您可以在最近完成的研究中看到,存在差異。有時,這些差異與他們如何計算修改後的梅奧評分的某些方面有關。但這很難預測,關於這項研究我先到此為止。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Actually, why don't you take the olanzapine one as well?
事實上,為什麼不也服用奧氮平呢?
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Oh, yes. And olanzapine LAI studies that have just come online. So that's part of our European submission package that we're running for a PK analysis of the olanzapine LAI.
哦是的。奧氮平 LAI 研究剛上線。這是我們歐洲提交包的一部分,我們正在對奧氮平 LAI 進行 PK 分析。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks, Eric. And then on UZEDY, yes, we're obviously very pleased with the work the team have done and showing the capability of driving growth in that market. I think what I'd say with regard to olanzapine, yes, we believe we have a real asset in olanzapine, a real unmet need because there hasn't been a long-acting olanzapine in the market.
謝謝,埃里克。然後在 UZEDY 上,是的,我們顯然對團隊所做的工作非常滿意,並展示了推動該市場成長的能力。我想我想說的是,關於奧氮平,是的,我們相信我們在奧氮平方面擁有真正的資產,這是一個真正未滿足的需求,因為市場上還沒有長效奧氮平。
I think we've shown in a congested market where UZEDY if we have a differentiated product, and a quality team behind in what we can do. That gives us a lot of optimism for olanzapine because of the unmet medical need and the fact that we will be coming to this market, maybe not a standing start.
我認為,我們已經在擁擠的市場中展示了 UZEDY 如果我們擁有差異化的產品,並且擁有一支優質團隊,我們就能做到這一點。這讓我們對奧氮平非常樂觀,因為醫療需求未被滿足,我們將進入這個市場,也許不是一個長期的起點。
If I remind everybody, with UZEDY, that came along. And we really didn't do the level of prelaunch that we would like to do normally. And so I think the team have done a good job in picking up the ball and getting running quickly. That won't be the case with olanzapine. We know the positions.
如果我提醒大家,UZEDY 已經出現了。我們確實沒有達到我們通常希望做的預發布水平。所以我認為球隊在接球和快速跑動方面做得很好。奧氮平則不會出現這種情況。我們知道職位。
We know the payers, we know the hospitals. We know the (inaudible) committees we have to. We've got good relationships with them because we have a good asset in UZEDY.
我們了解付款人,我們了解醫院。我們了解我們必須了解的(聽不清楚)委員會。我們與他們有著良好的關係,因為我們在 UZEDY 擁有良好的資產。
And so for us, the ability to prepare ourselves and to make sure the market is prepared for olanzapine. I think we put ourselves in a very good position. What that looks like is a potential. I think as we start to really get into the detail of the data and understanding the landscape with regard to key opinion leaders and payers and patients. We will clarify that.
因此,對我們來說,我們有能力做好準備並確保市場為奧氮平做好準備。我認為我們把自己置於一個非常有利的位置。看起來就是一種潛力。我認為,當我們開始真正了解數據的細節並了解關鍵意見領袖、付款人和患者的情況時。我們會澄清這一點。
But we're very optimistic and very enthusiastic about it. Thanks for the questions, Umer.
但我們對此非常樂觀和熱情。謝謝你的提問,烏默。
Operator
Operator
Our next question comes from Balaji Prasad of Barclays.
我們的下一個問題來自巴克萊銀行的巴拉吉·普拉薩德。
Balaji Prasad - Analyst
Balaji Prasad - Analyst
Congratulations on the results and great to see the all around growth and pipeline progress. But firstly, I wanted to start off with a bigger thematic question, Richard. So making America had received significant push under the previous Trump presidency, especially as a supply chain situation post-COVID exposed the US generic vulnerabilities (inaudible) likely to be a priority again, I think. In such an event, is there a structural tailwind?
祝賀結果,很高興看到全面的成長和管道進展。但首先,我想從一個更大的主題問題開始,理查德。因此,我認為,在川普上任總統期間,「打造美國」受到了巨大的推動,特別是在新冠疫情後的供應鏈情勢暴露出美國的普遍漏洞(聽不清楚)的情況下,這可能會再次成為優先事項。在這種情況下,是否存在結構性順風?
Or how can Teva leverage such a possible push in the generics in biosimilars as well? And what does it do for margins in the longer run? That's one.
或者梯瓦如何利用生物相似藥中仿製藥的這種可能推動?從長遠來看,它對利潤率有何影響?這是一個。
Two, on the pipeline front, we recently hosted a (inaudible) call on olanzapine LAI. We discussed in-depth around the no monitoring requirement and said that's needed for it to be a big drug, a $1 billion drug. So with the safety data available till now, can you comment on your expectations or confidence with such a label?
第二,在管道方面,我們最近舉辦了一次關於奧氮平 LAI 的(聽不清楚)電話會議。我們圍繞無監測要求進行了深入討論,並表示這是一種大藥物、一種價值 10 億美元的藥物所必需的。那麼,根據目前可獲得的安全數據,您能否評論一下您對這樣的標籤的期望或信心?
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks, Balaji. Thanks for the question. I'll take the first one, which is a tricky one because obviously, we're dealing in something that's happened real-time. I think first and foremost, I'd like to point out that Teva as any company, I'm sure that's a global company, works with any administration productively. So I think we'll do that here.
謝謝,巴拉吉。謝謝你的提問。我將採取第一個,這是一個棘手的問題,因為顯然,我們正在處理即時發生的事情。我認為首先也是最重要的是,我想指出,梯瓦公司與任何一家公司一樣,我確信這是一家全球性公司,可以與任何政府部門進行富有成效的合作。所以我想我們會在這裡這樣做。
And with regards to, is there any policy changes which impact the generic market? And then obviously, as a major player -- the major player in the US generic market, I think that's something that if it benefits a company like Teva then obviously, that is helpful.
是否有任何政策變化影響仿製藥市場?顯然,作為美國仿製藥市場的主要參與者,我認為如果這對梯瓦這樣的公司有利,那麼顯然這是有幫助的。
But I think for us, we'll have to wait and see how that plays out. I think what you're talking about is something that may happen, but I think it still hasn't crystallized. So over the next in a few months, actually, until into next year when the administration is actually in place as soon as we see what that looks like, then we can probably comment more on that in other earnings. But maybe to hand the other question on olanzapine over to Eric.
但我認為對我們來說,我們必須等待,看看結果如何。我認為你所說的是可能發生的事情,但我認為它還沒有具體化。因此,實際上,在接下來的幾個月裡,直到明年政府實際上就位時,一旦我們看到了情況,我們就可以在其他收益中對此進行更多評論。但也許要把另一個關於奧氮平的問題交給艾瑞克。
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Yes. So to review for the olanzapine LAI program and what we've designed the program in conjunction with the FDA, as we mentioned before, we've exceeded, as expected, the targeted number of injections that we need for the submission package. We have not seen any PDSS in real time at this point. We'll have our last patient coming towards the end of the year. But we're excited because the scientific story is very strong, I believe, when it comes to our formulation.
是的。因此,為了審查奧氮平 LAI 計劃以及我們與 FDA 聯合設計的計劃,正如我們之前提到的,我們已經超出了提交包所需的目標注射次數。目前我們還沒有看到任何即時的 PDSS。我們將在年底迎來最後一位患者。但我們很興奮,因為我相信,當涉及到我們的配方時,科學故事非常強大。
It's designed to control spikes in the PK. It's a subcutaneous shot, so it's very unlikely to hit a large vessel like our competitors have a problem with. And we have a clinical data set and Phase I data that shows in very intensive PK that we don't have this problem. I think at the end of the day, though, it also -- there's an important unmet medical need for patients. They need an option for olanzapine in a long-acting injectable.
它旨在控制 PK 中的峰值。這是皮下注射,因此不太可能像我們的競爭對手那樣擊中大型血管。我們有一個臨床數據集和一期數據,在非常密集的 PK 中顯示我們沒有這個問題。不過,我認為歸根究底,患者還有一個重要的未滿足的醫療需求。他們需要一種長效注射劑中的奧氮平選擇。
So I think with all those things, the fact that we've design this in conjunction with the FDA. I think that our chances here are good. That's always going to be a review question for the FDA, but I think that we've checked all the boxes.
所以我認為,考慮到所有這些事情,事實上我們是與 FDA 一起設計的。我認為我們在這裡的機會很好。這始終是 FDA 的審查問題,但我認為我們已經檢查了所有的方框。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks, Eric. Thanks for the questions, Balaji.
謝謝,埃里克。謝謝你的提問,巴拉吉。
Operator
Operator
Our next question comes from David Amsellem of Piper Sandler.
我們的下一個問題來自 Piper Sandler 的 David Amsellem。
David Amsellem - Analyst
David Amsellem - Analyst
So just to ask a couple of quick ones. First, can you comment on how you're thinking about US generics for 2025, particularly interested in products that can offset pressure on (inaudible) dynamics there. And how you're thinking about new contributors to the US generic/biosimilar portfolio in '25 beyond, say, Stelara?
所以只是簡單地問幾個問題。首先,您能否評論一下您對 2025 年美國仿製藥的看法,特別是對能夠抵消(聽不清楚)動態壓力的產品感興趣。您如何看待 25 年後美國仿製藥/生物相似藥組合的新貢獻者,例如 Stelara?
So that's number one. And then number two is, as you looking at the UZEDY (inaudible), I was wondering where you're getting patients from? Are these switches from oral risperidone? Are you getting switches from other oral (inaudible)? I'm just interested in the patient mix?
所以這是第一。第二個問題是,當您查看 UZEDY(聽不清楚)時,我想知道您從哪裡獲得患者?這些是口服利培酮的轉換嗎?您是否從其他口頭轉換(聽不清楚)?我只是對患者組合有興趣?
And then the third one, if I may, is just how you're thinking long term about any impact on LAI antipsychotics from the availability of muscarinic agonists in schizophrenia?
第三個問題,如果可以的話,您是如何長期考慮毒蕈鹼激動劑在精神分裂症中的應用對 LAI 抗精神病藥物的影響?
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks for the questions, David. I think I'll give my view on those and then maybe ask Eric to chime in. So on the US generics business for 2025, obviously, we'll give guidance on that at the start of the year. But let me sort of help answer your question at least a bit and how we're thinking about it.
謝謝你的提問,大衛。我想我會對此發表自己的看法,然後可能會請 Eric 插話。 因此,對於 2025 年的美國仿製藥業務,顯然,我們將在年初給出指導。但讓我至少回答一下你的問題以及我們是如何考慮這個問題的。
Yes, obviously, the team have done a great job with Revlimid. But I'd also like to add that we have launched other complex generics in the US this year with Victoza, octreotide, and Forteo and others. And so that's part of, obviously, we get the benefit of those when we move into '25. But we also have some good launches planned for '25 with Symbicort, Saxenda, et cetera.
是的,顯然,該團隊在 Revlimid 方面做得非常出色。但我還想補充一點,今年我們在美國推出了其他複雜的仿製藥,包括 Victoza、奧曲肽、Forteo 等。顯然,當我們進入 25 世紀時,這就是我們從中受益的一部分。但我們也計劃在 25 年推出一些不錯的產品,包括 Symbicort、Saxenda 等。
So I think we've already shown as we focus on launching our generics and our complex generics, we have the ability to do that better than we've done in the past. We then add into that, as you've highlighted, our biosimilars, biosimilar Humira, biosimilar Stelara, that obviously, you put that together collectively. I think that gives -- puts us in a very good position to manage the change that we're going to have with Revlimid in 2026.
因此,我認為我們已經表明,當我們專注於推出仿製藥和複雜仿製藥時,我們有能力比過去做得更好。然後,正如您所強調的那樣,我們添加了我們的生物仿製藥、生物仿製藥 Humira、生物仿製藥 Stelara,顯然,您將它們放在一起。我認為這使我們處於一個非常有利的位置來管理我們將在 2026 年透過 Revlimid 實現的變革。
So that's how we think about it. With regard to UZEDY, I'll sort of start a bit and I'll like Eric to give a sort of physician's point of view as well as the new entrants.
這就是我們的想法。關於 UZEDY,我會先講一點,我希望 Eric 能夠給出一種醫生的觀點以及新進者的觀點。
So you UZEDY, there's a couple of things, I think, that we benefited from. One is a great product profile. So it's a really good product profile. And because of that, physicians see the benefit of using it over other long-actings. That ability to get to therapeutic dose within 8 to 24 hours is really critical when you have a patient who's having an episode.
UZEDY,我認為我們從以下幾件事中受益。一是出色的產品簡介。所以這是一個非常好的產品簡介。正因為如此,醫生們看到了使用它比其他長效藥物的好處。當患者出現發作時,在 8 至 24 小時內達到治療劑量的能力非常重要。
Then we have some more practical ones about subcutaneous prefilled syringes out of the refrigerator or important when dealing -- when working in these institutions. And the second is we have a great commercial team here in the US that's really focused on executing, understanding the dynamics of the market, understanding the dynamics when it comes to physicians, payers, patient journey. (inaudible) capability we have at Teva, which maybe people didn't appreciate. So those are the things that have driven it, and we're taking it from both orals and we're taking it from other long-actings.
然後,我們有一些關於皮下預充式註射器的更實用的信息,這些注射器從冰箱中拿出來,或者在交易時很重要——在這些機構工作時。其次,我們在美國擁有一支出色的商業團隊,他們真正專注於執行、了解市場動態、了解醫生、付款人和患者旅程的動態。 (聽不清楚)我們在 Teva 擁有的能力,也許人們並不欣賞。這些就是推動它的因素,我們從口服藥物和其他長效藥物中獲取它。
What is interesting, we are getting a lot from orals. So showing that when people reach for a long-acting, they're reaching for UZEDY more and more. But then actually, when it comes to question the long-acting they're on, then they also reach for UZEDY more and more. So I think that just goes to show that product profile. Now before I hand over to Eric, I would say new entrants to the market, actually, we think, is a good thing because, one, optionality for patients is good, but it stimulates the market even more.
有趣的是,我們從口頭中得到了很多東西。這表明,當人們尋求長效藥物時,他們會越來越多地選擇 UZEDY。但實際上,當談到質疑他們所使用的長效藥物時,他們也會越來越多地使用 UZEDY。所以我認為這只是為了展示產品概況。現在,在我交給艾瑞克之前,我想說,實際上,我們認為市場的新進者是一件好事,因為,第一,病人的選擇權很好,但它更刺激了市場。
And so for us, with good products like used and olanzapine, we think we can benefit from that.
因此,對我們來說,憑藉二手產品和奧氮平等優質產品,我們認為我們可以從中受益。
But maybe I'll hand over to Eric.
但也許我會把工作交給艾瑞克。
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Yes. When it comes to UZEDY and its product profile -- and I've been very encouraged by the uptake of UZEDY because when we developed it, we are always proud of the product profile. I mean, it's a prefilled syringe. It's subcutaneous. The PK -- the drug levels get up to active levels in 24 hours.
是的。當談到 UZEDY 及其產品簡介時,我對 UZEDY 的採用感到非常鼓舞,因為當我們開發它時,我們總是為產品簡介感到自豪。我的意思是,這是一個預充式註射器。這是皮下的。 PK-藥物濃度在 24 小時內達到活性水準。
There's no PO supplementation. We're already presenting data showing how people can switch onto this very convenient product. When you're a bit in the psychiatrist office it's very busy. You want to be able to have something ready and easily administered to your patients. So that's what I've been proud of.
沒有 PO 補充。我們已經提供了數據,展示了人們如何轉向這種非常方便的產品。當你在精神科醫生辦公室的時候,那裡會很忙。您希望能夠準備好一些東西並輕鬆地為您的患者進行管理。這就是我一直感到自豪的事情。
And as far as muscarinic -- there's new muscarinic treatments for schizophrenia. We keep a close eye on that. We're very happy to see new MOAs come into this field. It is a BID oral medication, though. And there will be also step-throughs when it comes to reimbursement and the use of other generic treatments.
至於毒蕈鹼-有治療精神分裂症的新毒蕈鹼療法。我們密切關注這一點。我們很高興看到新的 MOA 進入這個領域。不過,它是一種 BID 口服藥物。在報銷和使用其他非專利治療方面也會有逐步的步驟。
So though if it's a BID oral treatment adherence has been and always will be a problem with this population, and that's why it's a different value proposition when it comes to our long-acting injectables.
因此,儘管如此,如果是 BID 口服治療,那麼依從性一直是且永遠是該人群的一個問題,這就是為什麼當涉及到我們的長效注射劑時,它是一個不同的價值主張。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks for the questions, David.
謝謝你的提問,大衛。
Operator
Operator
Our next question comes from Jason Matt Gerberry of Bank of America.
我們的下一個問題來自美國銀行的 Jason Matt Gerberry。
Jason Gerberry - Analyst
Jason Gerberry - Analyst
Just on TL1A for the fourth quarter update, just wanted to confirm that we'll get placebo-adjusted UC mayo remission scores at week 14, just so we have some relative sense of benchmarking against competitors? And is the Crohn's subgroup power to show stats? And then just on TAPI, can you just maybe give us an update where you're at in the process that underpins confidence for a first half '25 close of that, and you've made really good progress on the net debt deleveraging. So really just trying to get a handle on some of these legal matters like the recent European fine? Like is that something that you take a cash hit on more in the near term?
就在 TL1A 的第四季度更新中,只是想確認我們將在第 14 週獲得經過安慰劑調整的 UC 梅奧緩解分數,這樣我們就可以對競爭對手的基準進行一些相對的感覺?克羅恩病亞組是否有能力顯示統計數據?然後就TAPI 而言,您能否向我們介紹一下您在這一過程中所處的最新情況,以支撐25 年上半年結束時的信心,並且您在淨債務去槓桿化方面取得了非常好的進展。那麼,真的只是想解決一些法律問題,例如最近的歐洲罰款嗎?您是否會在短期內投入更多現金?
Or given the multiyear appeals process, something that maybe there's not a cash hit for a while?
或者考慮到多年的上訴過程,可能暫時不會有現金打擊?
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks, Jason. Thanks for the question. I think I'll hand the first one to Eric.
謝謝,傑森。謝謝你的提問。我想我會把第一個交給艾瑞克。
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Yes. Thank you. I appreciate the question. So yes, both ulcerative colitis and Crohn's disease is placebo-controlled in the study and we will provide the placebo-adjusted numbers. That's critical in thinking about Umer's question early on, the placebo is key.
是的。謝謝。我很欣賞這個問題。所以,是的,潰瘍性結腸炎和克隆氏症在研究中都是安慰劑對照的,我們將提供安慰劑調整後的數據。這對於儘早思考烏默的問題至關重要,安慰劑是關鍵。
And I would remind you, too, that this is the first placebo-controlled randomized study for Crohn's disease with this MOA. So we're proud to be the first one to do that, and that's what we're targeting to give you.
我還要提醒您,這是第一個使用這種 MOA 治療克羅恩病的安慰劑對照隨機研究。因此,我們很自豪能夠成為第一個做到這一點的人,這就是我們的目標是為您提供的。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
And I'll maybe tag team this with Eli a bit. So just starting on the TAPI, we're well on track with that, and we should be in a position to complete that (inaudible) in H1 of 2025, as we've already previously announced. With regard to debt, before I hand that to Eli, just on the European announcement. I'd just like to point out that, as you saw in our press release, we don't agree with that decision, and we are going to appeal that. And that will take many, many years, unfortunately, but we are going to appeal it because we don't agree with it.
我可能會用 Eli 來標記這個團隊。因此,從 TAPI 開始,我們就已經步入正軌,並且我們應該能夠在 2025 年上半年完成(聽不清楚),正如我們之前宣布的那樣。關於債務,在我將其交給 Eli 之前,就歐洲公告而言。我只想指出,正如您在我們的新聞稿中看到的那樣,我們不同意這一決定,我們將對此提出上訴。不幸的是,這將需要很多很多年,但我們將上訴,因為我們不同意它。
And so there's no cash impact in the short term because of that. And we think we have a good case.
因此,短期內不會對現金產生影響。我們認為我們有一個很好的案例。
With that, I'll hand it over to Eli to maybe comment if there's any questions relating to debt or?
這樣,如果有任何與債務有關的問題,我會將其交給 Eli 來發表評論。
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Yes. So thank you, Jason. So first of all, about the -- you asked also about what does it mean in terms of the EU commission fine in terms of cash. So for the coming several years, we don't see this one as a cash event. We were able to structure with certain levels of facilities in order to accommodate any pledge that we required to do as part of the appeal process until the final judgment.
是的。所以謝謝你,傑森。首先,您也詢問了歐盟委員會的現金罰款意味著什麼。因此,在接下來的幾年裡,我們不認為這是一場現金活動。我們能夠建造一定程度的設施,以適應我們在最終判決之前作為上訴過程的一部分所需做出的任何承諾。
As far as related to the net debt and deleveraging, as I mentioned in my prepared remarks, in October, we made another payment of maturities. So for '24, we don't have any of these. But we do have in the first quarter of '25, around $1.4 billion, one in January, one in March, in total, $1.4 billion. So next year, it's kind of more front-loaded in terms of debt payment. But that will actually -- we will be able to manage it versus our organic free cash flow generation and our ongoing prediction.
至於淨債務和去槓桿,正如我在準備好的發言中提到的,10月份我們又進行了一次到期付款。所以對於 24 年,我們沒有這些。但我們在 25 年第一季確實有大約 14 億美元,一月份一個,三月一個,總共 14 億美元。所以明年,在債務償還方面會更提前。但這實際上 - 我們將能夠根據我們的有機自由現金流產生和我們正在進行的預測來管理它。
Other than that, we're still constantly looking on the market to decide if and when we will need to require to make any refinancing plan heading to the '26 and '27 towers.
除此之外,我們仍在不斷關注市場,以確定是否以及何時需要為 '26 和 '27 塔樓制定任何再融資計劃。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks, Eli, and thanks for your question, Jason.
謝謝伊萊,也謝謝你的提問,傑森。
Operator
Operator
Our next question comes from Chris Schott of JPMorgan.
我們的下一個問題來自摩根大通的克里斯·肖特。
Christopher Schott - Analyst
Christopher Schott - Analyst
Just a couple of quick ones for me. Maybe just on the pipeline first on emrusolmin. Can you just talk about, is there a filing pathway for this one based on the Phase I? Or we have to think about a Phase III kind of program coming from there? My second question was on TL1A and to the extent the Phase II data reads out successfully.
對我來說只有幾個快速的。也許只是在 emrusolmin 上首先在管道上。您能不能談談,這個一期的基礎上有沒有一個備案途徑?或者我們必須考慮來自那裡的第三階段項目?我的第二個問題是關於 TL1A 以及第二階段資料是否成功讀出。
Just curious how quickly you can move that forward into Phase III just given the competitive landscape that's out there?
只是好奇考慮到現有的競爭格局,您能以多快的速度將其推進到第三階段?
And then finally, just a bigger picture one. Can you just talk about overall level of investment going on at Teva right now? You've obviously accelerated the pipeline. You've made some really good investments on that front. But to the extent we continue to see kind of this momentum in the core business, how should we think about that upside flowing through the P&L versus going into incremental investments and further accelerating some of these growth drivers?
最後,只是一張更大的圖景。您能談談梯瓦目前的整體投資水準嗎?顯然,您已經加速了流程。您在這方面做了一些非常好的投資。但就我們繼續在核心業務中看到這種勢頭而言,我們應該如何看待損益表上的上升趨勢,而不是進行增量投資並進一步加速其中一些成長動力?
I'm (inaudible) a sense of like do we reach a point where there is more of it flowing down to the bottom line? Or should we think about kind of a balanced approach as you invest in the business?
我(聽不清楚)有種感覺,我們是否已經達到了有更多的資金流向底線的地步?或者當你投資業務時我們應該考慮平衡的方法?
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks, Chris. Thanks for the questions. First two, I'll give to you Eric. And then the next one investment, I'll start and maybe ask Eli to also contribute. So over to you, Eric.
謝謝,克里斯。感謝您的提問。前兩個,我會給你艾瑞克。然後下一項投資,我會開始,也許會要求 Eli 也做出貢獻。那就交給你了,艾瑞克。
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Yes. So I'll take the second one first on TL1A, our Duvakitug program. We're running this in partnership with Sanofi. And one of the great things about the partnership is we've already started a year ago. We've started this relationship, and we're working very closely with them.
是的。所以我將首先討論 TL1A(我們的 Duvakitug 程式)的第二個。我們正在與賽諾菲合作這項工作。這種合作關係的一大好處是我們在一年前就已經開始了。我們已經開始了這種關係,並且正在與他們密切合作。
So as soon as we get the data, we're preparing to as rapidly as possible to start Phase III with them targeted in 2025, and we'll have further announcements in that -- about that next year.
因此,一旦我們獲得數據,我們就會準備好盡快啟動第三階段,目標是 2025 年,我們將在明年發布進一步的公告。
The emrusolmin, I did mention that we're trying to make that Phase II study as robust as possible. It's 200 patients placebo-controlled with one active arm. This is a great unmet medical need. These patients need treatment. So if we see responses in there, I'll be the first one to push for an approval and an accelerated pathway, but it's all going to be dependent on the data, but that's certainly our hope for these patients.
emrusolmin,我確實提到過,我們正在努力使 II 期研究盡可能可靠。 200 名患者使用一隻主動臂進行安慰劑對照。這是一個巨大的未滿足的醫療需求。這些患者需要治療。因此,如果我們看到那裡的回應,我將是第一個推動批准和加速途徑的人,但這一切都將取決於數據,但這肯定是我們對這些患者的希望。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
And then on the final question around investments. I think I'll probably start with reiterating how we think about capital allocation at Teva. And the first part of that, when we announced the Pivot to Growth was obviously to pay down debt. Then it was to invest in our growth drivers and then to do BD. Now as we've -- as you've highlighted, Chris, we made really great progress on driving our innovative portfolio in the market, but also accelerating our pipeline.
然後是關於投資的最後一個問題。我想我可能會先重申我們對梯瓦資本配置的看法。當我們宣布轉向成長時,第一部分顯然是為了償還債務。然後是投資我們的成長動力,然後進行業務拓展。現在,正如克里斯您所強調的那樣,我們在推動市場創新產品組合方面取得了巨大進展,同時也加快了我們的研發進程。
So for us, this is always about creating long-term sustainable value. And to do that, we've had the opportunity and the need to invest in these potential growth drivers. As we've done, I think that very thoughtfully, to make sure we manage our OpEx level.
所以對我們來說,這始終是為了創造長期可持續的價值。為此,我們有機會也有必要投資這些潛在的成長動力。正如我們所做的那樣,我認為這是經過深思熟慮的,以確保我們管理我們的營運支出水準。
And as you hear from Eli, on a regular basis, the percentage of OpEx versus revenue is something we focused on and we're keeping constant. So we think about that balance very carefully. What do we need to invest to create a sustainable long-term growing business, but also what do we do to make sure we can increase value for shareholders. And that's something which we do think about. I don't think we ever think that that's -- there's one extreme or the other, I think we need to try and deliver both over the medium and long term.
正如您從 Eli 那裡聽到的那樣,我們經常關注營運支出與收入的百分比,並且保持不變。所以我們非常仔細地考慮這種平衡。我們需要投資什麼來創造可持續的長期成長的業務,以及我們如何確保我們能夠為股東增加價值。這也是我們確實會考慮的事情。我認為我們從來沒有想過——有一個極端或另一個極端,我認為我們需要嘗試在中長期實現這一目標。
And that's why we're committed to that 30% operating margin in 2027. But we need to do that thoughtfully to make sure that we're not missing out on opportunities to drive long-term growth in the short term. So maybe that's my opening statement. Eli, do you have anything to add to that?
這就是為什麼我們致力於在 2027 年實現 30% 的營業利潤率。也許這就是我的開場白。 Eli,還有什麼要補充的嗎?
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
I will just add, Chris, if you go back in the last three quarters year-to-date, we generate in total-wise, $600 million incremental gross profit versus year-to-date year ago. We really kind of allocate around 45% from that one into -- back to OpEx to invest in the business and the rest really flow through and enable us to expand our margin, be it the EBITDA expansion. I think that pattern we will try to manage as we move forward with how Richard mentioned and how we're going to position our capital allocation.
克里斯,我只想補充一點,如果你回顧今年迄今為止的最後三個季度,我們與去年同期相比總共產生了 6 億美元的增量毛利。我們實際上將大約 45% 的資金分配回營運支出來投資業務,其餘的資金真正流向並使我們能夠擴大利潤,無論是 EBITDA 擴張。我認為,隨著我們繼續推進理查德提到的以及我們將如何定位我們的資本配置,我們將嘗試管理這種模式。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks Eli. Thanks for your questions, Chris. Appreciate it.
謝謝伊萊。謝謝你的提問,克里斯。欣賞它。
Operator
Operator
Our next question comes from Ash Verma of UBS.
我們的下一個問題來自瑞銀集團的 Ash Verma。
Ash Verma - Analyst
Ash Verma - Analyst
So I just wanted to clarify on the API business. You've kind of accumulated a $1 billion impairment charge in the last two quarters. What's sort of driving that? Is there some material change in the business conditions? And then how does that impact the divestment discussions that you're having?
所以我只是想澄清一下API業務。在過去的兩個季度中,您已經累積了 10 億美元的減損費用。是什麼樣的驅動力?經營狀況是否有重大變動?那麼這對你們正在進行的撤資討論有何影響?
And then on the TL1A, I wanted to understand the rationale for the endpoint selection here. So for CD, you're looking at endoscopic response as the primary end point. Some of the KOL feedback suggests that it's a harder endpoint to show meaningful benefit in a short-term study like this versus (inaudible) you sort of have a more realistic clinical remission end point, if you can comment on that?
然後在 TL1A 上,我想了解這裡端點選擇的基本原理。因此,對於 CD,您將內視鏡反應視為主要終點。一些 KOL 回饋表明,在像這樣的短期研究中顯示有意義的益處是一個更難的終點,而(聽不清楚)你有一個更現實的臨床緩解終點,如果你能對此發表評論嗎?
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Ash, thanks for your questions. I'll have the TAPI one to Eli and then Eric, if you can take the TL1A.
阿什,謝謝你的提問。如果您能參加 TL1A,我會將 TAPI 一份交給 Eli,然後交給 Eric。
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Eliyahu Kalif - Chief Financial Officer, Executive Vice President
Thank you, Ash. So related to TAPI, internally, as you know, Tape is a stand-alone unit, and it includes both commercial and operational functions. Now with the ongoing progress of the potential carve-out, we are reviewing constantly our allocated net assets, including the goodwill, which is kind of the legacy assets in that perspective and adjusting it for the potential expected deal structure. The impairment has no connection to the great performance that we have with TAPI as long as with the business plan that we are projecting.
謝謝你,阿什。因此與 TAPI 相關,在內部,如您所知,磁帶是一個獨立的單元,它包括商業和營運功能。現在,隨著潛在剝離的持續進展,我們正在不斷審查我們分配的淨資產,包括商譽,從這個角度來看,商譽是一種遺留資產,並根據潛在的預期交易結構對其進行調整。減損與我們在 TAPI 的出色表現無關,與我們規劃的業務計劃無關。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks, Eli. And then the next question, Eric?
謝謝,伊萊。那麼下一個問題,艾瑞克?
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Yes. Ash, thanks for the question. For Crohn's disease, yes, our primary endpoint is endoscopic endpoint. You're right, that is more challenging on the short end of the study to show a difference. Our key secondary endpoint is the clinical remission.
是的。阿什,謝謝你的提問。對於克隆氏症,是的,我們的主要終點是內視鏡終點。你是對的,在研究的短期內顯示差異更具挑戰性。我們的關鍵次要終點是臨床緩解。
So those two should be a good judge of the activity of the compound.
所以這兩個應該可以很好地判斷化合物的活性。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks, Eric. Thanks for your questions, Ash.
謝謝,埃里克。謝謝你的提問,阿什。
Operator
Operator
Our next question comes from Yifeng Liu of HSBC.
我們的下一個問題來自匯豐銀行的劉一峰。
Yifeng Liu - Analyst
Yifeng Liu - Analyst
I've got two questions. One, could you talk about how you're seeing the pricing environment of generic medicine this year and how you see it evolve maybe into 2025? And the second question is also on TL1A. Could you maybe tell -- share a bit more color on the baseline split between UC and the Crohn's disease across your three groups, if that's possible?
我有兩個問題。第一,您能否談談您如何看待今年仿製藥的定價環境以及您認為它如何演變到 2025 年?第二個問題也是關於TL1A的。如果可能的話,您能否分享一下您的三個組別中 UC 和克羅恩病之間基線劃分的更多顏色?
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thank you for the questions. So let me start on the generic one on pricing. So there's nothing that's changed in the pricing environment in the US Obviously, the general pressure is downward because of the nature of the business. And so the way we tackle that is by launching new products, and improving our product supply and our cost of goods.
謝謝你的提問。那麼,讓我從有關定價的通用問題開始。因此,美國的定價環境沒有任何變化。因此,我們解決這個問題的方法是推出新產品,並改善我們的產品供應和商品成本。
And that's something which we've been focused on significantly for the last 20 months. And so for us, when we look about pricing pressures for 2025, we expect the market to be the same. Our general point of view on this is prices will be pushed down.
這是我們過去 20 個月來一直重點關注的事情。因此,對我們來說,當我們考慮 2025 年的定價壓力時,我們預計市場將保持不變。我們對此的總體看法是價格將會被壓低。
And so how we offset that is by launching more products, as we've talked about in the US, and we do this regularly in the EU and international markets and then improving our supply chain. And I think we've shown, we have improved in this area, and we're doing that better, and that's hence the reason you'll see the performance of our business being robust and strong across all regions.
因此,我們如何抵消這一影響是透過推出更多產品,正如我們在美國談到的那樣,我們在歐盟和國際市場定期這樣做,然後改善我們的供應鏈。我認為我們已經表明,我們在這一領域已經取得了進步,而且我們做得更好,這就是為什麼您會看到我們的業務在所有地區表現強勁。
And then maybe hand over TL1A question to you, Eric.
然後也許會將 TL1A 問題交給你,Eric。
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
Eric Hughes - Executive Vice President, Global R & D, Chief Medical Officer
And I hope I'll interpret your baseline split question correctly. But in the study, it's designed that it's fixed, half of the study is ulcerative colitis, and half of the study is containing Crohn's disease patients. When it comes to the baseline characteristics of the patients, they're both going to be moderate to severe patients, a good proportion will probably be biologically experienced patients up taking to have up to three different biologics and/or some advanced oral therapies. And we'll probably have about half of them have experienced a steroid use as well.
我希望我能正確解釋你的基線分割問題。但在研究中,它被設計成固定的,一半的研究是潰瘍性結腸炎,一半的研究包含克羅恩病患者。當談到患者的基線特徵時,他們都將是中度至重度患者,很大一部分可能是具有生物學經驗的患者,接受最多三種不同的生物製劑和/或一些先進的口服療法。我們可能會有大約一半的人也使用過類固醇。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Thanks, Eric.
謝謝,埃里克。
Operator
Operator
I'll now hand back to Richard Francis for any closing remarks.
現在我將邀請理查德·弗朗西斯發表結束語。
Richard Francis - President, Chief Executive Officer
Richard Francis - President, Chief Executive Officer
Okay. Well, thank you once again for your interest in Teva Pharmaceuticals. I appreciate the questions and your time. Hopefully, you see once again in quarter three our execution of our Pivot to Growth strategy continues to gain momentum. We continue to execute on the things we said we're going to execute on, and they have continued to deliver performance and value.
好的。好吧,再次感謝您對梯瓦製藥的興趣。我感謝您的提問和您的時間。希望您在第三季再次看到我們對成長策略的執行繼續獲得動力。我們繼續執行我們說過要執行的事情,他們也繼續提供績效和價值。
We look forward to giving you an update for quarter four at the start of next year and to give you guidance for next year. Thanks very much. Have a good day.
我們期待在明年初向您提供第四季度的最新情況,並為您提供明年的指導。非常感謝。祝你有美好的一天。
Operator
Operator
Thank you all for joining today's call. You may now disconnect your lines.
感謝大家參加今天的電話會議。現在您可以斷開線路。